Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding (Mirena IUD)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by Scott and White Hospital & Clinic.
Recruitment status was:  Recruiting
Information provided by:
Scott and White Hospital & Clinic Identifier:
First received: July 7, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
Problematic uterine bleeding after the insertion of the LNG IUS is a well documented side effect. The levonorgestrel intrauterine system (LNG IUS) was approved for treatment of heavy menstrual bleeding (HMB) by the FDA in October 2009. To reduce the incidence and severity of post-insertional uterine bleeding, pretreatment with norethindrone acetate may effectively slough the endometrium prior to insertion of the LNG IUS.

Condition Intervention Phase
Heavy Menstrual Bleeding
Drug: Norethindrone acetate pretreatment
Other: No pretreatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pretreatment With Norethindrone Acetate Prior to Levonorgestrel IUS Insertion for Heavy Menstrual Bleeding

Resource links provided by NLM:

Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:
  • Total number of bleeding days [ Time Frame: up to 180 days ]
    Number of days on study calendars with menstrual flow

Secondary Outcome Measures:
  • Menorrhagia Questionnaire [ Time Frame: up to 180 days ]
    Patients will assess the impact of their menstrual bleeding on their lifestyle.

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Norethindrone acetate pretreatment
This arm will receive two cycles of norethindrone acetate before LVN IUS insertion.
Drug: Norethindrone acetate pretreatment
5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
Other Name: Aygestin
No pretreatment
LVN IUS is placed without norethindrone acetate pretreatment.
Other: No pretreatment
LVN IUS is placed withour Norethindrone acetate pretreatment.

Detailed Description:
This study will examine whether or not pretreatment with oral norethindrone acetate prior to the insertion of a hormonal intrauterine device will affect post-insertional uterine bleeding. The subjects enrolling in the study will have documented heavy menstrual bleeding (HMB) and desire the levonorgestrel intrauterine system (LNG IUS) (Mirena®, Bayer, Inc. Pittsburgh, PA) for symptomatic relief. HMB for this study is defined as heavy bleeding at regular intervals at least 20-40 days apart. Subjects will be randomized to one of two groups. One group will receive norethindrone acetate for two consecutive months prior to LNG IUS insertion while the other group will proceed with direct insertion of the LNG IUS with no hormonal pre-treatment. Subjects will be followed for a period of 180 days post LNG IUS insertion. Bleeding patterns will be recorded daily.

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • You must be between 18-45 years old
  • You have Heavy Periods

Exclusion Criteria:

  • You are pregnant
  • You are currently using hormonal contraception or hormonal therapy
  • You have a history of pelvic inflammatory disease (and have not had a normal pregnancy since)
  • You had an infected abortion within the last three months
  • You have abnormal or cancerous cells of the cervix or uterus
  • You have an actine infection in your genital organs
  • Known or suspected breast cancer
  • Active liver disease or tumors
  • Allergy to levonorgestrel or norethindrone
  • You currently have deep vein thrombosis, pulmonary embolism, or history of these conditions
  • you currently have active or recent (within the past year) arterial thromboembolic disease (such as a stroke or myocardial infarction) these conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01391052

Contact: Wendy M White, CCRP 254-724-8301

United States, Texas
Scott and White Hospital and Clinic Recruiting
Temple, Texas, United States, 76508
Contact: Wendy M White, CCRP    254-724-8301   
Principal Investigator: Patricia J Sulak, MD         
Sponsors and Collaborators
Scott and White Hospital & Clinic
Principal Investigator: Patricia J Sulak, MD Scott and White Hospital & Clinic
  More Information

Responsible Party: Patricia Sulak, MD/principal investigator, Scott and White Hospital & Clinic Identifier: NCT01391052     History of Changes
Other Study ID Numbers: 90378
Study First Received: July 7, 2011
Last Updated: July 7, 2011

Keywords provided by Scott and White Hospital & Clinic:
Intrauterine system
reproductive age
menstrual bleeding

Additional relevant MeSH terms:
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Menstruation Disturbances
Norethindrone acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs processed this record on May 25, 2017